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The PAD Trial is a prospective, multicenter, randomized clinical study testing whether volunteer, non-medical responders can improve survival from out-of-hospital cardiac arrest (OOH-CA) by using automated external defibrillators (AEDs). These lay volunteers, who have no traditional responsibility to respond to a medical emergency as part of their primary job description, will form part of a comprehensive, integrated community approach to the treatment of OOH-CA. The study is being conducted at 24 field centers in the United States and Canada. Approximately 1000 community units (e.g. apartment or office buildings, gated communities, sports facilities, senior centers, shopping malls, etc.) were randomized to treatment by trained laypersons who will provide either cardiopulmonary resuscitation (CPR) alone or CPR plus use of an AED, while awaiting arrival of the community's emergency medical services responders. The primary endpoint is the number of OOH-CA victims who survive to hospital discharge. Secondary endpoints include neurological status, health-related quality of life (HRQL), cost, and cost-effectiveness. Data collection will last approximately 15 months and is expected to be completed in September 2003.

Background The Public Access Defibrillation (PAD) Trial was a randomized, controlled trial designed to measure survival to hospital discharge following out-of-hospital cardiac arrest (OOH-CA) in community facilities trained and equipped to provide PAD, compared with community facilities trained to provide cardiopulmonary resuscitation (CPR) without any capacity for defibrillation. Objectives To report the implementation of community-based lay responder emergency response programs in 1,260 participating facilities recruited for the PAD Trial in the United States and Canada. Methods This was a descriptive study of the characteristics of participating facilities, volunteers, and automated external defibrillator (AED) placements compiled by the PAD Trial, and a qualitative study of factors that facilitated or impeded implementation of emergency lay responder programs using focus groups of PAD Trial site coordinators. Results The PAD Trial enrolled 1,260 community facilities (14.8% residential), with 20,400 lay volunteers (mean +/- standard deviation = 13.4 +/- 10.7 per facility) trained to respond to OOH-CA. The 598 locations randomized to receive AEDs required 2.7 +/- 1.8 AEDs per facility. Volunteer attrition was high, 36% after two years. Barriers to recruitment and implementation included identification of appropriate "at-risk" facilities, lack of interest or fear of litigation by a facility key decision maker, lack of motivated potential volunteer responders, training and retraining resource requirements, and lack of an existing communication/response infrastructure. Conclusions These data indicate that implementation of community-based lay responder programs is feasible in many types of facilities, although these programs require substantial resources and commitment, and many barriers to implementation of effective PAD programs exist.

(1981). The Bladderless Dog: A New Animal Model for Use in Experimental Xenobiology. Drug Metabolism Reviews: Vol. 12, No. 2, pp. 293-324.

Cefonicid kinetics were determined after intravenous and intramuscular injection and the renal handling of the drug was examined, including the effect of probenecid on its excretion. Peak serum levels after 1000 and 500 mg intravenously were 221 and 91 μg/ml. The half-life (t½) was the same for both regimens (3.5 hr). Intramuscular injection of the 1000- and 500-mg doses resulted in peak serum levels of 112 and 40 μg/ml. When probenecid was given with the 500-mg dose, the peak serum level was 61 μg/ml and the time to peak level rose from 13 to 2.5 hr. The t½ after 1000 and 500 mg alone was much the same at 4.8 and 4.9 hr. The addition of probenecid to the 500-mg dose extended the t½ to 7.5 hr. Renal clearance, excretion, and secretion rates for cefonicid were reduced by the addition of probenecid. Cefonicid's long t½ and high blood levels max provide clinical efficacy with a single daily dose. Clinical Pharmacology and Therapeutics (1981) 30, 587–593; doi:10.1038/clpt.1981.208

The kinetics and renal handling of ceftizoxime were examined after intravenous and intramuscular injection and the effect of probenecid on its excretion was investigated. Peak serum level after 1000 mg IV was 60.5 μg/ml and half-life (t½) was 1.4 hr. Peak serum level (40.9 μg/ml) was reached 1 hr after 1000 mg IM. When probenecid was added to the 1000-mg IM dose the peak level was 44.3 μg/ml at 1 hr and serum levels at 2, 4, 6, and 8 hr were all higher than after ceftizoxime alone (P < 0.01). The 1.85-hr t½ of ceftizoxime alone was extended to 2.29 hr when probenecid was added. Ceftizoxime was shown to be actively secreted by the renal tubule; this secretion was decreased by probenecid. Clinical Pharmacology and Therapeutics (1982) 31, 516–521; doi:10.1038/clpt.1982.69

Smith Kline & French uses a fourth generation database language because both the databases and data access programs can be modified quickly. Because we have such a powerful development tool, our clinical studies program is being developed at a rapid pace. Another tool used in support of clinical studies is a data dictionary package which fully defines all data files and data items. The primary uses of this dictionary are creating documentation and generating file descriptions of the clinical databases using a special dictionary interface. The dictionary also allows us to standardize data items and their definitions across several clinical studies. Smith Kline & French Labs is in the process of developing a standard way of collecting all clinical data items; however, these standards are not firmly defined. Our approach is to capture all the data required by the user. Since this is a new approach for us, the exact definition of what “all the data” is can never be finalized. We must allow our users to create...